August 3rd Week, 2025 Regulatory Events 🎯 Health Canada granted approval to Merck & Co./ MSD 's pembrolizumab (anti-PD-1) mono as a...

18/08/2025 Izalontamab brengitecan received the Breakthrough Therapy Designation by the US FDA for EGFR-mutated NSCLC ( Ref ) The US FDA...

July 4th Week, 2025 Regulatory Events 🎯 The EC approved Bayer and Orion Pharma ’s darolutamide (androgen receptor inhibitor) +...

July 3rd Week, 2025 Regulatory Updates 🎯 Corcept Therapeutics submitted an NDA to the US FDA for relacorilant (selective cortisol...

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer ( Ref )...

July 2nd Week, 2025 Regulatory Updates 🎯 The EC approved BeOne Medicines ' tislelizumab (anti-PD-1) + gemcitabine + cisplatin for the...

08/07/2025 Adagene and ConjugateBio sign a partnership agreement to develop novel ADC ( Ref ) Adagene announced a partnership with...

23/06/2025 Datroway has been approved in the US for locally advanced or metastatic EGFR-mutated NSCLC ( Ref ) The US FDA approved...

18/06/2025 The Phase 3 IDeate-Prostate01 trial of ifinatamab deruxtecan has been initiated in pretreated, metastatic CRPC patients ( Ref...

June 3rd Week , 2025 Regulatory Events 🎯 The US FDA approved the updated labelling of Pfizer ’s talazoparib (PARP inhibitor) +...

May 5th Week, 2025 Regulatory Events 🎯 The EC approved Bristol Myers Squibb ’s subcutaneous nivolumab (Opdivo Quantig; anti-PD-1)...

May 3rd Week, 2025 Regulatory Events 🎯 Incyte and MacroGenics, Inc. ’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel has been...

May 2nd Week, 2025 Special Designations ⭐ The US FDA granted the Fast Track designation to Adcentrx Therapeutics ’ ADRX-0706 (Nectin-4...

April 2nd Week, 2025 Regulatory Events 🎯 AstraZeneca and Daiichi Sankyo ’s trastuzumab deruxtecan (HER2 ADC) mono has been approved...

March 3rd Week, 2025 Regulatory Events 🎯 The US FDA granted traditional approval to Merck & Co./ MSD ’s pembrolizumab (anti-PD-1) +...

March 1st Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb ’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by...

Highlights from the Committee for Medicinal Products for Human Use (CHMP) January 2025 Meeting are out! Here are the positive...